cool hit counter Xue Xiangdong: Blockchain is necessary and feasible to break the legislative bottleneck and promote the development of big data industry in health care_Intefrankly

Xue Xiangdong: Blockchain is necessary and feasible to break the legislative bottleneck and promote the development of big data industry in health care

In recent years, the country has elevated the construction of healthcare big data applications to the level of national strategy, and from our research, the lag in big data legislation at the national level has seriously affected the further implementation of the healthcare big data strategy. In response, some provinces and cities, such as Fuzhou, have adopted the Interim Measures for the Management of Health Care Big Data Resources in Fuzhou City, initiating the practice of local legislation on health care big data. But the bottleneck of healthcare big data legislation is the security of healthcare data storage, sharing and transaction. If this hidden worry cannot be completely solved, the industrial development and legislative practice of healthcare big data cannot be fundamentally broken. To regulate and promote the development of the healthcare big data industry, we believe that it is feasible to use blockchain to break the bottleneck of healthcare big data legislation.

▌ I. Urgency and Bottlenecks of Health Care Big Data Legislation

Health care big data refers to the collection of clinically and management-related data generated in the course of medical services that meet the basic characteristics of big data, including electronic medical record data, medical imaging data, medication records, etc. In addition to the 4V characteristics of general big data, healthcare big data also has characteristics unique to the healthcare domain such as large scale, diverse types, fast growth, huge value, time-series, privacy and incompleteness. The five main application modes of health care big data are patient characteristics, disease type, treatment plan, cost, treatment status and management data, which are currently used in important areas such as intelligent assisted treatment, image data analysis and image intelligent diagnosis, rational drug use, remote monitoring, precision medicine, cost and efficacy analysis, performance management, hospital cost control and medical quality analysis.

(i) Big data in health care as a national strategy

The 2015 Outline of Action to Promote the Development of Big Data (Guo Fa [2015] No. 50), specifies the general requirements regarding the use of data. The Guiding Opinions on Promoting and Regulating the Development of Health Care Big Data Applications (Guo Ban Fa [2016] No. 47) at the end of June 2016, clearly put forward that health care big data is an important national fundamental strategic resource, and that the development of health care big data applications will bring about profound changes in the health care model, which is conducive to stimulating the momentum and vitality of deepening the reform of the medical and health system, improving the efficiency and quality of health care services, expanding the supply of resources, continuously meeting the multi-level and diversified health needs of the people, and fostering new business models and economic growth points.

(ii) Urgency of legislation on big data in health care

With the rapid development of big data industry, Beijing, Shanghai, Guizhou and other places actively layout big data trading platform, general data trading is increasingly active, the development momentum is good and promising, but health care big data is constrained by the lagging legislation, the contradiction between supply and demand is very prominent. On the one hand, health care institutions, health care authorities and health insurance departments are unwilling, afraid and will not open and share health care data: out of the department's own perspective, they recognize the importance of health care data and thus are unwilling to open it; due to the lack of legal and standard support, they are worried about data security and dare not share it; constrained by data technology research and development bottlenecks, they cannot do open and share it. On the other hand, the scale of underground trade in health care data is huge, and the illegal collection, theft, trafficking and exploitation of patient information are rampant, even forming a chain of industry.

(iii) Bottlenecks in health care big data legislation

The current obstacles to the implementation of the national strategy of health care big data in China no longer lie in policy support and guidance, but firstly in imperfect laws and regulations and lagging legislation related to health care big data; secondly, the core security issues of health care big data are both the focus of legislative regulation and restraint and the difficulty of supervision, thus becoming the bottleneck of health care big data legislation. For the problem of lagging legislation, although the State Office issued [2016] No. 47 document has proposed "strengthening the construction of regulations and standard systems, formulating and improving laws and regulations on the development of health care big data applications, strengthening the standardized management of residents' health information services, clarifying the authority to use information, and effectively protecting the legitimate rights and interests of relevant parties. "However, the chronic and lagging state of legislation at the national level has become a major obstacle to the implementation of the national health care big data strategy at all levels of health care institutions and health authorities. Therefore, local regulations on health care big data should be established and improved to guide and regulate the development and working practice of the health care big data industry.

▌ II. Logical Starting Point for Health Care Big Data Legislation

From a review of local practice and research on local legislation on big data in health care, the main considerations are.

(i) Need for legislation to regulate and enable openness and sharing of health care information

Medical institutions at all levels, health authorities and health insurance management agencies all hold a large amount of health care data resources, but due to the compartmentalized administrative system, these data have become "information islands". Therefore, legislation is needed to scientifically define health care data resources, clarify the scope, content, manner and procedures of opening and sharing health care data resources, and establish a monitoring and guarantee mechanism to safeguard health care data sources and ensure data quality.

This is also in line with national policy requirements, as the document "Several Opinions of the State Council on Promoting Information Consumption and Expanding Domestic Demand" (Guo Fa [2013] No. 32) clearly calls for the opening of public data resources, proposing "the development of management methods for the opening and sharing of public information resources, and promoting the opening of information resources by municipal public enterprises and institutions, public service institutions and other institutions". The State Council's Guidance on Actively Promoting "Internet+" Action (Guo Fa [2015] No. 40) proposes to "promote the opening up of data resources". The Action Plan for Promoting the Development of Big Data (Guo Fa [2015] No. 50) proposes to "steadily promote the opening up of public data resources".

(ii) Need for legislation to regulate the trading of health care data

The legality of big data transactions in health care is an important issue at the moment, concerning the fundamental rights of patients in the free flow of data, intellectual property rights in big data transactions, restrictions on personal information in big data transactions, and the possibility that transnational transactions in big data may endanger national security. The issue of intellectual property rights therein requires legislation to clarify the boundaries of health care data trading and use, to determine the intellectual property rights and data management rights of health care databases and data products, and to provide a more stable and reliable legal rights basis for data trading with clear boundaries.

(iii) Need for legislation to regulate the protection of health-care data

Many developed countries in Europe and the United States enacted privacy laws and data protection laws as early as the 1970s and 1980s, while China's National People's Congress has introduced some basic regulations for privacy protection, but they are too macro at the operational level, and the industry is crying out for compliance guidelines for health care data flow. Therefore, there is an urgent need to formulate relevant laws and regulations and promote the establishment of medical and health data standards.

Health care data legislation is critical to health care management, public health, and even economic development. The legislation is conducive to the development of the healthcare big data industry and also safeguards the security of personal health information from a regulatory perspective, thus making healthcare big data available for market use and serving pharmaceutical companies, hospitals and doctors for precision treatment and health management. Health care data legislation needs to consider the following three aspects: (1) clarify the privacy information and sensitive information in health care data, which should be strictly de-privatized and desensitized, and have a corresponding regulatory system; (2) clarify the absolute right of patients to own their own health data, and open convenient ways to enable patients to get their own health, treatment data, and truly serve the health of patients; (3) clarify the constraints of the market in using health care data, and prevent these data from being maliciously searched, analyzed and used, thus threatening the security of personal and organizational information.

▌III. Blockchain technology facilitates breaking legislative bottlenecks

(i) Blockchain medicine to break the bottleneck of health care big data legislation

The security of healthcare data storage, sharing and transaction, although it can be regulated and bound by legislation, is still a difficult point to regulate in the Internet environment and the cost of regulation is very high, thus becoming a bottleneck of healthcare big data legislation. Medical blockchain for the distributed transmission, aggregation, storage and analysis of patient clinical and treatment data utilization, through the confirmation of mutual trust agreement to reach consensus to maintain the security and trust of data, so that the sharing and opening of health care big data can be achieved on a safe and legal basis. Therefore, healthcare blockchain is a fundamental technical guarantee to break the bottleneck of healthcare big data legislation and ensure healthcare big data legislation and enforcement.

Blockchain is essentially a distributed bookkeeping technology that can be seen as a database of decentralized nodes from a data perspective. It is not held by one party, but all parties participate in the bookkeeping together, using some signed private keys and consensus mechanism algorithms. The blockchain's own technical features are more applicable to the healthcare scenario as the actions of all parties are traceable and ensure that data is not tampered with or corrupted. The distributed structure of blockchain can be applied to medical data sharing; the timestamp feature of non-falsifiable can solve the problems of data and equipment traceability and information anti-counterfeiting; the advantages of its high redundancy and complex custody authority of multiple private keys can solve the security authentication defects of current medical information technology; the flexible programmable feature can help hospitals establish expanded applications, etc. This allows us to establish a mechanism of mutual trust and sharing through blockchain technology to regulate medical practices, which in turn provides an innovative way to establish a new, transparent and trustworthy relationship between hospitals, health insurance and medicine.

(ii) Promoting the development of health care big data industry with medical blockchain

Medical blockchain can further stimulate the momentum and vitality of deepening the reform of the medical and health system, improve the efficiency and quality of health care services, and promote the new development of China's health care big data applications.

First, we will improve the universal health information platform, accelerate interconnection and promote the construction of regional platforms. The unique properties of healthcare blockchain provide an immutable and trusted workflow with a "single source of truth" to ensure the integrity of healthcare data exchange, minimize cybersecurity threats, and increase healthcare data governance applications. The focus of blockchain is the potential to have a shared platform that decentralizes the interaction of healthcare data while ensuring access control over the exchange of protected healthcare information, ensuring its authenticity and integrity. Thus, blockchain will greatly improve the efficiency of building regional platforms.

Second, to promote the construction of personal health records and health management. Blockchain, an open source tool for peer-to-peer data sharing network models, provides identity management capabilities through predefined user access rules to increase patient control over their health data and the reliability of patient engagement programs; in addition, permanent storage of encrypted patient health data on an immutable blockchain system provides a single, simplified view of patient data; in turn, it also allows consumers to selectively share their anonymous personal health data for research, direct payment rewards, and health tokens to encourage healthy behaviors and other health programs.

Third, precision medicine. Blockchain technology and its secure infrastructure for seamless integration of health data promises to facilitate unprecedented collaboration between industry players, academia, researchers and patients, enhance innovation in medical research, and implement larger scale population genomic studies, thereby facilitating the development of precision medicine. As drug development invests heavily in precision medicine, blockchain-based, time-stamped immutable records may eliminate the burden and cost of clinical trial data reconciliation and facilitate interoperability and study sharing.

Comprehensive analysis of the above, the application of medical blockchain can be a good solution to the security regulatory problems of opening and sharing of health care big data, cracking the bottleneck of health care big data legislation, thus promoting the big development of China's health care big data industry forward.

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